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Monthly Injectable Atypical Antipsychotic Reduces Schizophrenia Relapse Rate: Presented at APA

By Charlene Laino

WASHINGTON, DC -- May 9, 2008 -- In patients with schizophrenia, paliperidone palmitate, an injectable, long-acting form of the atypical antipsychotic drug paliperidone, significantly delays the time to first recurrence, a phase 3, randomized, double-blind, placebo-controlled study showed.

David Hough, MD, a consultant to Johnson & Johnson Pharmaceutical Research & Development in Princeton, New Jersey, presented the findings here on May 6 at the 2008 Annual Meeting of the American Psychiatric Association. Dr. Hough also has a private practice at the Psychiatric Services of Princeton, also in Princeton, NJ.

In the complex design, 849 patients whose total Positive and Negative Syndrome Scale (PANSS) scores were less than 120 were transitioned from prior treatment to gluteal muscle injections of paliperidone palmitate for a 9-week open-label flexible-dose phase. The first 2 injections of 50 mg equivalent (eq) were given 1 week apart. Subsequent injections were given every 4 weeks and could be adjusted to 25, 50, or 100 mg eq.

A subgroup of 681 patients with total PANSS scores of less than 75 entered into a 24-week maintenance phase. Patients who were clinically stable on a fixed dose for the last 12 weeks of this phase were then randomized in a 1:1 double-blind fashion to continue on their dose (n = 205) or were switched to placebo (n = 203).

Reasons for dropping out in all phases of the study included patient choice, adverse events, or criteria not being met.

An Independent Data Monitoring Committee recommended that the study be terminated early because the significant efficacy of paliperidone palmitate over placebo at a preplanned interim analysis of 68 recurrent events (P < .0001), Dr. Hough said. A total of 312 patients were included in the analysis at that point, 156 in each arm, he said.

The median time to first recurrence was 163 days for patients on placebo; among patients taking paliperidone palmitate the time to first recurrence could not be estimated because the number of patients who had relapsed was too low (P < .0001), Dr. Hough said.

Of 156 patients treated with paliperidone palmitate, 10% experienced recurrent events versus 34% of 156 in the placebo arm, a statistically significant difference, Dr. Hough said in an interview.

The most common reasons for recurrence were an increase in the PANSS score or an increase in individual PANSS items, he said.

Four of the 408 patients in the double-blind phase of the study dropped out due to adverse events. Of the 203 patients on placebo, 1 experienced a myocardial infarction. Among the 205 patients on paliperidone palmitate, there was 1 dropout due to epilepsy, 1 due to oculogyration, and 1 due to weight increase.

Adverse events occurring in at least 5% of patients were similar in the 2 treatment arms, with the exception of weight gain, which occurred in 7% of patients in the paliperidone palmitate arm group versus 1% in the placebo group.

From the clinician's perspective, "using an injectable agent ensures that the drug gets into the blood," Dr. Hough said. "You're not relying on the patient to remember to take oral agents every day."

From the patient's perspective, "some people might prefer the convenience of a once-a-month injection," he said.

The next step will be a randomized, controlled trial comparing the injectable agent to an oral antipsychotic, according to Dr. Hough.

Funding for this study was provided by Johnson & Johnson Pharmaceutical Research & Development.


[Presentation title: Paliperidone Palmitate in Prevention of Symptom Recurrence in Patients With Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. Abstract NR4-029]

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